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Head of QMS

Kaliber Labs is seeking an experienced Head of QMS to lead our quality efforts and help us push the boundaries of medical AI applications. We're a highly collaborative, mission-driven company and are looking for someone who's excited about what we're building at Kaliber and eager to contribute his/her/their expertise to the development of our products.



Ideally, candidates will have a background in software as a medical device and prior experience setting up QMS efforts in support of FDA Class II medical devices.

Primary Responsibilities

  • Set up, manage, and grow Kaliber's QMS functions.

  • Effectively communicate and coordinate with outside QMS consultants to execute their recommendations in setting up QMS functions.

  • Evaluate, select, and implement an electronic QMS application.

  • Ensure that Kaliber has policies, processes, and procedures in place to facilitate successful internal audits and external audits for the FDA and ISO 13485.

  • Define and implement quality system documentation, including procedures, work instructions, non-conformances, CAPA, and associated investigations for areas of responsibility.

  • Plan, schedule, manage, conduct, and report on internal audits of Kaliber and site processes and records to ensure compliance with applicable quality and regulatory standards.

  • Foster a close working relationship with the science, R&D, engineering, product, and other relevant teams in order to ensure that all objectives are met.

  • Act as an agent of change and continual improvement through audits and delivery of objective and impact-driven audit observations.

  • Lead external audit readiness activities to ensure preparedness for inspections by regulators and/or notified bodies. Develop roles, workflows, and training for audit regulators and/or notified bodies. Develop roles, workflows, and training for audit participants and support personnel.

  • Perform regulatory intelligence activities to provide organizational foresight on changing regulations and inspection trends. Apply regulatory intelligence in audit plans and sampling strategies.

  • Perform compliance and/or gap assessments vis-a-vis regulations or standards for the purposes of planning improvement initiatives or change projects.

  • Maintain the metrics required to monitor compliance of the internal audit program and escalate issues when necessary.

Qualifications

  • BS or MS degree in engineering or life sciences.

  • 5+ years of relevant experience in setting up and leading QMS for regulations and standards for Class II medical devices.

  • Ideally will have experience in SaMD or familiarity with software product development, in addition to traditional medical device expertise.

  • Previous experience working in a fast-paced and/or startup environment.

  • Hands-on manager who can write SOPs and implement quality control procedures.

  • Excellent communicator who pays great attention to detail.

  • Highly collaborative multi-tasker who knows how to manage multiple deadlines.

Benefits

  • Competitive compensation, Series B equity

  • Medical, dental, and vision insurance

  • Breakfast, lunch, and dinner when we return to the office (our office lunches are quickly gaining a reputation as some of the best in town)

  • Unlimited vacation

  • Opportunity to collaborate with world-renowned surgeons to help shape the future of surgery

  • And to sweet the deal: the opportunity to design your desk, happy hours, team outings, and more

Contact

To apply for this position, send your resume to jobs@kaliberlabs.com.

About Kaliber Labs

Kaliber Labs brings machine learning experts and top surgeons together to deliver advanced solutions to the surgical setting. We're on a mission to give surgeons the tools they need to achieve better patient outcomes, expand access to proficient care, and improve surgical training.

Kaliber Labs is an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.